VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST— 510(k) K083088
Substantially EquivalentNanosphere, Inc.
FDA 510(k) clearance K083088 for VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST, Substantially Equivalent on 2009-05-01. Applicant: Nanosphere, Inc.. Device class: 2.
Clearance details
- Applicant
- Nanosphere, Inc.
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northbrook, IL, US
Recent devices under product code OCC
view allMore clearances from Nanosphere, Inc.
view all- K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
- K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
- K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
- K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
- K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.